Central venous catheters, originally introduced as vascular access for short-term dialysis, have been an acceptable form of permanent vascular access in some patients, particularly those with limited alternative options for vascular access. Approximately 17-18% of hemodialysis patients select tunneled cuffed catheter as long-term vascular access. Despite great advances, two major causes of catheter loss continue to plague sustained effective hemodialysis (HD) treatment: lumen clot formation (LCF) and catheter-related infection (CRI).
Some reports suggest up to 42% of catheter-related dysfunction is attributable to LCF, and a prospective study suggested that catheter-dependent HD patients have a 35% probability of developing bacteremia within three months of catheter insertion. Given the high percentage of dialysis patients who develop LCF and CRI, management that mitigates these rates may prove itself invaluable.
Multiple studies have assessed the role of catheter lock solutions for the prevention of LCF and CRI. Antibiotic lock solutions demonstrated a reduction in CRI, however, there is growing concern that their overuse enables the development of antibiotic resistance. Furthermore, it has been concluded that there is no ideal catheter lock solution to completely prevent catheter loss due to LCF and CRI.
The common method to ensure patency of the catheter is locking them with heparin at concentration of about 1000 U/mL to 10,000 U/mL. However, each hemodialysis center uses different concentration of heparin and there is no unified standard. There are downsides to utilizing heparin as a lock solution. For example, when using a heparin lock solution for indwelling venous catheter, bleeding complications have been reported and heparin was found to alter coagulation studies.
The American Diagnostic and Interventional Society of Nephrology recommends locking catheter with a low concentration (approx. 1000 U/mL) heparin solution or 4% trisodium citrate (TSC) as the low concentration heparin and TSC impart a relatively low bleeding risk for the patient.
Notwithstanding the above, even after one removes and discards the catheter lock solution, the remaining heparin attached to the wall of lumens could have an anticoagulation effect when later used. Thus, there is a need for an improved lock solution for catheters as prior solutions are not adequate.
For example, U.S. Pat. No. 8,747,911 pertains to a catheter lock composition for preventing bacterial infection having an effective amount of glycerol and sodium chloride solution. The effective amount of glycerol is between about 35-60% and sodium chloride is in a concentration range between 0.5-0.9%. The composition further includes an anticoagulant and/or an antimicrobial agent.
U.S. Pat. No. 7,132,413 pertains to compositions and methods for preventing formation of thrombosis on a liquid-contacting surface of a liquid delivery system, such as a port, catheter or port-catheter system. The liquid delivery system is connected to a patient for delivery of a liquid to the patient. The method involves contacting the surface with a thrombosis-preventing liquid containing taurolidine, taurultam or a mixture thereof, the thrombosis-preventing liquid further containing an anticoagulant agent. In an alternative embodiment, the liquid-contacting surface of the delivery system is contacted with a solution containing an anticoagulant agent, and thereafter contacted with a solution containing taurolidine, taurultam or a mixture thereof.
Various systems and methodologies are known in the art. However, their structure and means of operation are substantially different from the present disclosure. The other inventions fail to solve all the problems taught by the present disclosure. At least one embodiment of this invention is presented in the drawings below and will be described in more detail herein.